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Quadriceps Function Prior to Anterior Cruciate Ligament Reconstruction

Primary Purpose

Rupture of Anterior Cruciate Ligament

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
cryotherapy
TENS
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rupture of Anterior Cruciate Ligament focused on measuring Anterior cruciate ligament, ACL

Eligibility Criteria

15 Years - 55 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Complete ACL rupture
  2. Age 15-55

Exclusion Criteria:

  1. Persons who cannot tolerate knee joint TENS.
  2. Persons who have a known allergy to cryotherapy
  3. Patients who are pregnant or who plan on getting pregnant during the 12-month follow-up period.

Sites / Locations

  • University of VirginiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

knee joint cryotherapy

TENS

No intervention

Arm Description

20 minutes of knee joint cryotherapy - ice bag application

continuous TENS for duration of the 1 hour exercise session

no modality intervention; just exercise

Outcomes

Primary Outcome Measures

Quadriceps muscle strength and inhibition using the quadriceps central activation ratio

Secondary Outcome Measures

Quadriceps H-reflex testing
International Knee Documentation Committee Subjective Knee Joint Evaluation
Visual Analog Scale
Tegner Activity Rating

Full Information

First Posted
September 2, 2009
Last Updated
March 4, 2011
Sponsor
University of Virginia
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1. Study Identification

Unique Protocol Identification Number
NCT00971451
Brief Title
Quadriceps Function Prior to Anterior Cruciate Ligament Reconstruction
Official Title
Quadriceps Function Prior to Anterior Cruciate Ligament Reconstruction
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Unknown status
Study Start Date
November 2007 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
December 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of Virginia

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Patients who are diagnosed with an isolated tear of the anterior cruciate ligament and scheduled for arthroscopic reconstruction using bone-patellar tendon-bone autograft will be recruited to participate. All subjects will be invited to participate in 2 weeks (2 supervised sessions per week) prior to their surgery. Each session will include supervised therapeutic exercises. Subjects will be randomly assigned to receive continuous transcutaneous electrical nerve stimulation (TENS) during each session or knee joint cryotherapy prior to each exercise session. The investigators will measure quadriceps function before and after this 2-week intervention (both sessions occur prior to reconstruction surgery). This study will also have a true control group that will not receive either exercise of modality intervention. The investigators will collect subjective and objective outcomes data at regularly scheduled post-operative visits.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rupture of Anterior Cruciate Ligament
Keywords
Anterior cruciate ligament, ACL

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
knee joint cryotherapy
Arm Type
Experimental
Arm Description
20 minutes of knee joint cryotherapy - ice bag application
Arm Title
TENS
Arm Type
Experimental
Arm Description
continuous TENS for duration of the 1 hour exercise session
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
no modality intervention; just exercise
Intervention Type
Other
Intervention Name(s)
cryotherapy
Intervention Description
20 minutes of knee joint cryotherapy - ice bag application
Intervention Type
Other
Intervention Name(s)
TENS
Intervention Description
continuous use of TENS during the exercise session
Primary Outcome Measure Information:
Title
Quadriceps muscle strength and inhibition using the quadriceps central activation ratio
Time Frame
Day 15
Secondary Outcome Measure Information:
Title
Quadriceps H-reflex testing
Time Frame
Day 15
Title
International Knee Documentation Committee Subjective Knee Joint Evaluation
Time Frame
Day 15
Title
Visual Analog Scale
Time Frame
Day 15
Title
Tegner Activity Rating
Time Frame
Day 15

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Complete ACL rupture Age 15-55 Exclusion Criteria: Persons who cannot tolerate knee joint TENS. Persons who have a known allergy to cryotherapy Patients who are pregnant or who plan on getting pregnant during the 12-month follow-up period.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joseph M Hart, Ph.D.
Phone
434-243-0256
Email
jmh3zf@hscmail.mcc.virginia.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph M Hart, Ph.D.
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joseph M Hart, PhD
Phone
434-243-0256
Email
jmh3zf@virginia.edu
First Name & Middle Initial & Last Name & Degree
Joseph M Hart, Ph.D.

12. IPD Sharing Statement

Learn more about this trial

Quadriceps Function Prior to Anterior Cruciate Ligament Reconstruction

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